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Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)


Description

This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.\~30 million people in the US have chronic kidney disease (CKD) and are at 5-15 fold greater risk of cardiovascular (CV) disease and mortality. A major factor contributing to increased CV risk in these patients is chronic elevation of sympathetic nervous system (SNS) activity. New therapeutic strategies to safely and effectively ameliorate SNS over-activity are of paramount importance to improve clinical outcomes in this highly prevalent and high-risk patient population. This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mind

Trial Eligibility

Inclusion Criteria: * stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation * stable renal function (no greater than a decline of eGFR of 1 cc/min/1.73 m2 per month over the prior 3 months) Exclusion Criteria: * severe CKD (eGFR\<15 cc/min) * diabetic neuropathy * autonomic dysfunction * any serious disease that might influence survival * anemia with hemoglobin \<10 g/dL * treatment with central α-agonists or monoamine oxidase (MAO) inhibitors * myocardial infarction or cerebrovascular accident within the past 6 months * uncontrolled hypertension (BP≥170/100 mm Hg) * low BP (BP\<100/50 mm Hg) * bradycardia (HR\<55 beats/min) * ongoing drug or alcohol abuse (defined as \>2 drinks/day in men, and \>1 drink/day in women) * surgery within the past 3 months * adjustment of antihypertensive medications within the past month * pregnancy or plans to become pregnant * psychosis * suicidal ideation * implanted electronic or metallic device such as a pacemaker * implanted hearing aid, bone plate, carotid stent, bone screw at or near the neck * carotid atherosclerosis * concurrent use of another stimulating device such as a transcutaneous electrical nerve stimulation (TENS) unit.

Study Info

Organization

Emory University


Primary Outcome

Change in mean Muscle Sympathetic Nerve Activity (MSNA) burst frequency (BF)


Outcome Timeframe Baseline, 8 weeks

NCTID NCT04099992

Phases NA

Primary Purpose TREATMENT

Start Date 2019-09-20

Completion Date 2025-08

Enrollment Target 150

Interventions

BEHAVIORAL Mindfulness-based stress reduction (MBSR)

BEHAVIORAL Health enhancement program (HEP)

DEVICE Transcutaneous Vagus Nerve Stimulation (tVNS)

DEVICE Sham-transcutaneous Vagus Nerve Stimulation (tVNS)

Locations Recruiting

Atlanta VA Medical Center

United States, Georgia, Atlanta


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